Associate Manager/Manager, Quality Assurance Inspection Management

Rensselaer, New York, US
Jul 13, 2018
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: This position is an integral part of the team that manages inspections through the prep, performance and follow up of items requested by international regulators. It supports regulatory inspection and partner audits in the creation and management of inspection content ensuring it is organized, current and readily accessible during operations. This position will help cross-functional teams prepare for and follow up on inspection items as well as performing duties in support of site inspection readiness.
The individual will work with department leaders to build an inspection readiness capability across the organization.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Inspection Readiness:
o Support and lead teams implementing practices and improvements to make IOPS inspection-ready at all times.
o Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
o Build and implement tools to improve IOPS inspection readiness; determine system improvments.
o Track internal findings and communicate updates, metrics and outstanding items to senior personnel when necessary.

• Inspection Execution:
o Liaison with partners on audit/inspection and quality related matters to provide guidance and advice.
o Respond to incoming inquires during inspections and audits and ensure timely and accurate responses.
o Participates on internal committees/teams, as required.
o Provide advice and direction to company departments on quality and regulatory issues.

• Additional Responsibilities:
o Cross-site (Tarrytown, Raheen) support of inspection readiness and inspection activities.
o Coordinate Regeneron information to support regulatory requests for paper inspections and/or observation responses.

Education and Experience:

• Requires BS/BA degree in Life Sciences or related field and 7+ years increasing responsibility in a GMP environment.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.